The invention concerns a device as set forth in the classifying portion of claim 1.
Numerous inflammations in the human or animal urogenital tract are to be attributed to a large number of widely varying germs or microbes. Thus for example the etiology of Fallopian tube inflammation (salpingitis) is polymicrobial. Aerobic and anaerobic germs, mycoplasmas and chlamydiae can be identified in that respect. That identification can be achieved on the one hand from the Douglas fluid surrounding the Fallopian tubes or by smears from the Fallopian tubes. Particularly for intracellularly growing chlamydiae proof based on cell-rich examination material has proven to be an indispensable prerequisite as the Douglas fluid has a low cell content and in addition has an anti-microbial effect. For that reason the smear is also to be preferred for other bacteria identification procedures.
A number of devices of the general kind indicated is known for taking biological or cytological smears of that kind. Such devices are generally usable a plurality of times insofar as a fresh swab is fixed on the swab carrier for each new smear. To take a smear on the Fallopian tube the devices are generally moved to the Fallopian tube through a trocar. For smears at other locations which are more readily accessible in the urogenital tract the use of a trocar however may possibly be unnecessary.
Thus for example U.S. Pat. No. 5,295,952 discloses such a device in which the two carrier portions are connected together by way of a positively locking connection which locks in the longitudinal direction of the swab carrier. Locking transversely with respect to the longitudinal direction of the swab carrier is effected by way of a tubular coupling portion which is fitted over the two carrier portions.
The known devices however suffer from a large number of disadvantages. Thus on the one hand they are distinguished by virtue of being of a relatively complicated structure which is susceptible to trouble. Thus for example securely and releasably fixing the swabs on the swab carrier can be achieved, not only having regard to the tightly constricted spatial conditions, only with a very high degree of structural complication and expenditure which on the one hand has an adverse effect on the manufacturing costs of the individual components.
In addition, this design configuration also involves the disadvantage that the swab has to be released from the swab carrier after the smear has been taken. That operation of releasing the swab from the swab carrier is generally possible however only by means of suitable aids or tools, the use of which however under some circumstances can entail contamination of the swab. Contamination of that kind however, even in a very small amount, can seriously falsify the examination result.
The swab with the smear generally has to be initially stored in a transportation fluid for subsequent evaluation in the laboratory. Depending on the respective duration of the period of time between the operation of taking the sample and evaluation thereof, even very slight contamination can result in damage to or impairment of the smear on the swab or however also the transportation fluid and can thus result in falsification of the examination result.
A further disadvantage lies in the relatively expensive and complicated cleaning and sterilization of the multiply re-usable components of the known devices. Contamination which is not removed, precisely at locations which involve difficulties of access within the mechanism of the devices and the thermally or chemically induced component stresses which occur in the cleaning and sterilization procedure can also have an adverse effect on the susceptibility to trouble of the devices.
The object of the invention is therefore that of providing a device of the kind set forth in the opening part of this specification, which is simple and inexpensive to produce and which does not suffer from the above-indicated disadvantages or which involves them only to a lesser degree and which in particular ensures examination results which are as unfalsified as possible.
Based on a device as set forth in the classifying portion of claim 1, that object is attained by the features recited in the characterizing portion of claim 1.
The invention entails the technical teaching that a device which is particularly simple and inexpensive to produce and which is reliable in operation and which ensures examination results which are as unfalsified as possible is achieved if the swab carrier comprises at least a distal carrier portion and a tubular proximal carrier portion, which are releasably connected together by way of a coupling portion which is introduced into the proximal carrier portion and which to release the connection between the two carrier portions is pulled in the proximal direction out of its seat in the distal carrier portion.
In that arrangement the coupling portion extends in a distal direction into a first axial opening at the proximal end of the distal carrier portion and locks the carrier portions relative to each in their longitudinal direction in such a way that the connection thereof is releasable by pulling the distal end of the coupling portion in the proximal direction out of the first axial opening. In that arrangement the coupling portion still extends in the proximal direction through the actuating grip so that it can be gripped at its proximal end and can be pulled in the proximal direction out of its seat in the distal carrier portion.
It will be appreciated that the movement of pulling the coupling portion out in the proximal direction does not have to involve a pure translatory movement. It is likewise possible for a translatory movement to be combined with a rotational movement about the longitudinal axis of the coupling portion, for that purpose. That may be desired or even necessary in particular when the coupling portion is locked in position in positively locking relationship.
By virtue of the connection between the carrier portions being simple to release, the distal carrier portion with the swab disposed thereon can be detached, after the smear has been taken, without that involving touching those regions which are to be separated from each other, possibly by means of special tools or the like, which could result in contamination. The distal carrier portion which is to be removed, with the swab carrying the smear, only has to be positioned over or introduced into the opening of the transportation vessel filled with the transportation fluid. The coupling portion is then gripped at its proximal end and pulled relative to the swap carrier in the proximal direction until it is released from its seat in the first opening in the distal carrier portion. In that way the distal carrier portion is released from the proximal carrier portion and can slide into the transportation vessel filled with transportation fluid, without coming into contact with other objects when that happens.
The operation of removing the distal carrier portion with the swab can be carried out quickly and in an uncomplicated fashion in no time at all. The removal operation can be carried out in any longitudinal position of the swab carrier. Preferably however it is effected in the first longitudinal position of the swab carrier as the swab with the smear is then disposed in the interior of the casing tube and is thus substantially protected from unintended contamination.
Preferably that longitudinal position is characterized by a resistance which is perceptible for the operator when actuating the displacement device. Further preferably that resistance is afforded by an end abutment which is provided in the displacement device or between the casing tube and the swab carrier and beyond which no further actuation of the displacement device is possible.
The swab carrier is preferably in the form of a one-trip or disposable portion. That ensures that the device is of a particularly simple structure which is inexpensive to produce and which operates reliably, as for example no fixing devices which are of a complicated structure and which are to be used a plurality of times are required for the swab and the carrier portions respectively.
Preferably the entire device is designed for single use. It will be appreciated that this eliminates the expensive procedure for cleaning and sterilizing the device after the smear has been taken. It is however also possible for only the distal carrier portion with the swab and possibly also the casing tube or parts thereof to be constructed as one-trip or disposable components, while the rest of the device with the displacement device is designed for multiple use.
In preferred embodiments of the device according to the invention the coupling portion has at least one distal locking part and at least one proximal locking part. In that arrangement the distal locking part co-operates lockingly and releasably in the distal direction with a first wall part of the distal carrier portion. The proximal locking part co-operates lockingly and also releasably in the proximal direction with a second wall part of the proximal carrier portion or the actuating grip. As a result, the distal carrier portion is locked in the distal direction and the proximal carrier portion or the actuating grip connected thereto is locked in the proximal direction, to the coupling portion, whereby the two mutually adjoining carrier portions are fixed relative to each in a simple fashion.
The releasable connection between the respective locking part and the respective carrier portion can be designed in known manner in the form of a releasable positively locking connection. For that purpose for example one or more detent elements which are resilient transversely with respect to the longitudinal direction and which are respectively arranged on the one component can engage into corresponding undercut configurations in the other component. In that case, the resilient detent elements can be arranged both on the coupling portion and also on the respective carrier portion or the actuating grip.
Preferably, the connection between the distal locking part and the distal carrier portion or the connection between the proximal locking part and the proximal carrier portion or the actuating grip can be designed in the manner of a frictional locking connection which is releasable in the axial direction of the coupling portion.
It will be appreciated however that, in other variants of the device, for the respective connection between the carrier portion and the coupling portion, it is also possible to select a combination of a positively locking connection and a frictional locking connection for the respective connection, or one of the connection can be formed by a frictional locking connection and one of the connections can be formed by a positively locking connection. It will be appreciated also that the two connections can be made or afforded in different ways.
The preferred variant with the frictional locking connections is distinguished in that the first and second wall parts can be of a particularly simple nature, in particular without undercut configurations or the like. That considerably reduces the manufacturing expenditure for the two carrier portions. Thus in the situation which is easiest to manufacture the wall parts in question are of a substantially cylindrical configuration.
Preferably in that arrangement to provide the releasable frictional locking connection the respective locking part is of an oversize, at least in a portion-wise manner, transversely with respect to its longitudinal direction, in relation to the first and second wall part respectively. Depending on the respective elasticity of the components to be paired, the oversize is such that on the one hand a sufficiently firm fit of the coupling portion in the respective component and thus sufficiently reliable locking of the carrier portions relative to each is guaranteed. On the other hand the oversize is such that the distal end of the coupling portion can still be pulled with the application of a reasonable amount of force out of its seat in the first opening in the distal carrier portion.
In other variants the oversize and thus the frictional engaging pairing is achieved by one or more spring elements which are resilient transversely with respect to the longitudinal direction and which are respectively arranged on the one component and which press by virtue of their biasing effect transversely with respect to the longitudinal direction against corresponding friction surfaces on the component coupled thereto. The biasing effect with which the spring elements bear against the friction surfaces of the other component and therewith also the locking threshold or release force achieved can be relatively accurately determined by the dimensioning of the spring elements without in that respect having to observe particularly close dimensional tolerances. That reduces the manufacturing expenditure for the components in question.
In this case the spring elements can form at least a portion of the respective first and second wall parts respectively. The spring elements can be arranged in other words on the respective carrier portion. Variants of the device according to the invention, which are particularly simple to produce, are however distinguished in that the distal or proximal locking part is of a resilient nature transversely with respect to its longitudinal direction and bears with a biasing effect against the respective wall part.
In a development of the invention which is desirable because it can be produced at low cost the first and second wall parts are of a substantially cylindrical configuration and the respective locking part is formed by a spiral-shaped part. In that case the spiral-shaped part is preferably formed by a suitably wound metal wire.
In further preferred developments of the device according to the invention the proximal carrier portion, at its distal end, for receiving the distal end of the coupling portion which is drawn out of the first axial opening, is of inside dimensions which substantially correspond to the inside dimensions of the first axial opening. That ensures that, when the coupling portion is pulled out of its seat in the first opening, a substantially constant pulling force is to be applied to the coupling portion, during the entire release operation. That avoids jerky movements which can arise when pulling out the coupling portion as a consequence of a reduction in the pulling force required for pulling out the coupling portion, which was not expected by the operator. That makes it easier to introduce the detached distal carrier portion with the swab carrying the smear, into the transportation container.
It will be appreciated however that, in other variants of the invention, a drop in the pulling force to be applied can be achieved by the proximal carrier portion at its distal end for example being of an inside dimension which is sufficiently great for receiving, substantially free of resistance, the distal end of the coupling portion, which end is pulled out of the first axial opening. Likewise by virtue of a suitable configuration of the coupling portion and the proximal carrier portion, it is possible to produce a rise in the force required for pulling out the coupling portion as soon as the coupling portion is released from the distal carrier portion in order to signal that condition to the operator.
Preferred variants of the device according to the invention are distinguished in that, at its end which projects in the proximal direction out of the actuating grip, the coupling portion has a grip device for pulling its distal end in a proximal direction out of the first axial opening. That permits the distal carrier portion with the swab to be quickly detached, without aids being required.
In accordance with a preferred development of the invention the device has at least one securing means to prevent the distal end of the coupling portion from being unintentionally pulled out of the first opening. The securing means can be designed in many known ways. Thus for example the securing means can comprise a releasable clamping device or the like which is arranged at the proximal end of the actuating grip in the exit region of the coupling portion and which fixes the coupling portion relative to the actuating grip and therewith also relative to the carrier portions of the swab carrier.
It is also possible to provide a releasable securing means which acts by positively locking, for example a securing pin or the like, which engages into suitable openings in the coupling portion and in the actuating grip.
Preferably the securing means is such that it is destroyed when the distal end of the coupling portion is pulled out of the first axial opening. For that purpose it may for example comprise an adhesive point consisting of a plastic material which suitably hardens and which is sufficiently firmly joined both to the material of the coupling portion and also the material of the component which in that region adjoins the coupling portion. It is equally also possible for the securing means to be in the form of a plastic diaphragm or the like which is shaped or molded on the coupling portion and which is then clamped fast for example in the seat of the proximal carrier portion in the actuating grip or which is fixed in some other fashion to those components.
These variants are distinguished by the securing means being particularly simple and thus inexpensive to produce. Such a securing means can be disposed at any locations of the coupling portion, for example at the exit of the coupling portion from the actuating grip, but also at the distal end of the proximal carrier portion or even in the first opening of the distal carrier portion.
In advantageous variants of the device according to the invention the securing means also forms the means for locking the coupling portion in the distal carrier portion or in the proximal carrier portion or the actuating grip, thereby providing that the device is of a particularly simple structure which is reliable in operation.
In other advantageous variants of the invention, it is provided that the coupling portion and the carrier portions are such that the carrier portions are fixed by the coupling portion transversely with respect to their longitudinal direction in a position of being substantially aligned in their longitudinal direction. That makes it unnecessary to provide corresponding guide means on the carrier portions, which hold the latter in their mutually aligned position.
In a further preferred embodiment of the device according to the invention the difference between the inside dimensions of the casing tube and the outside dimensions of the swab carrier or the swab is such that the end region of the swab carrier which is disposed distally of the first structural weakening is released after separation thereof from the casing tube by virtue of the action of the force of gravity when the casing tube is suitably inclined. That permits particularly simple handling of the sample on the swab, after the smear has been taken. It is sufficient in this case for example for the distal end of the device to be positioned perpendicularly above the opening of the filled transportation vessel and for the distal carrier portion to be removed in the above-described manner. The carrier portion which has been removed and on which is disposed the swab with the smear is then released from the casing tube as a result of the action of the force of gravity, and slides into the transportation fluid. This variant therefore also provides that the component of the device which carries the sample that is to be later analyzed passes into the transportation vessel without coming into contact with possible sources of contamination. Preferably, for that purpose, the inside dimensions of the casing tube in the distal end region have a slight oversize relative to the outside dimensions of the distal carrier portion or the swab.
The dimensional difference can however also be such that, in addition to the force of gravity, the action of weak inertia forces, for example due to gentle shaking or the like, also provides for release from the casing tube.
A further advantage of the device according to the invention in this respect is that, in the event of the separated distal carrier portion sticking in the casing tube, the coupling portion can be displaced in the distal direction again in order to release or push the distal carrier portion out of the casing tube.
Preferably the length of the distal carrier portion is substantially at least 1 cm, preferably at least 2 cm, and does not exceed an amount of substantially 10 cm, preferably 5 cm. That ensures simple appropriate transportation in transportation vessels which are in current use at the present time.
In advantageous developments of the invention the swab carrier, the casing tube and the displacement device are so designed that the swab carrier is rotatable about the longitudinal axis at least in its second longitudinal position relative to the casing tube. That ensures that a sufficiently large amount of sample can be easily taken, by the swab being brought into contact with the part of the body to be examined, by rotation about the longitudinal axis of the swab, over preferably its entire periphery. That is effected in accordance with the invention without the casing tube having to be rotated for that purpose. It is precisely in the case of a device which is inserted through a trocar that such rotation of the casing tube, by virtue of the generally relatively firm fit of the casing tube in the jacket tube of the trocar, is relatively difficult or involves the application of an increased amount of force, which once again could result in damage to the device.
The displacement device can be designed in many known ways. It is thus for example possible for the actuating grip to be guided relative to the grip element in known manner by means of a guide pin or the like which is arranged for example on the actuating grip and which engages into a corresponding guide groove extending in the grip element. Then, when the swab carrier is in the second longitudinal position, the guide groove must extend in the peripheral direction of the casing tube or swab carrier so that corresponding rotation of the swab carrier relative to the casing tube is possible.
Preferably in that case the swab carrier is rotatable relative to the casing tube through at least substantially a full revolution in order advantageously to make use of the entire periphery of the swab for taking the sample. It will be appreciated however that certainly satisfactory results can also be achieved with a smaller angle of rotary movement.
In the case of a variant which is particularly advantageous because it is simple to produce the actuating grip includes an advance device and a rotating device which is fixedly connected to the proximal end of the swab carrier. The rotating device and/or the swab carrier is or are arranged on the advance device and is or are rotatable relative thereto about the longitudinal axis. In that case for example the proximal end of the swab carrier can be supported rotatably in the advance device, wherein the swab carrier then projects in the longitudinal direction out of the advance device in the proximal direction. Arranged on the portion which projects out of the advance device there is then the rotating device which for example can be formed by a wheel or the like which is carried on the swab carrier or also only by a suitable grip surface on the swab carrier. Preferably however for reasons of strength the rotating device is supported rotatably on or in the advance device.
In further preferred embodiments of the invention the swab carrier or the casing tube and/or the displacement device are designed in such a way that the longitudinal mobility of the swab carrier relative to the casing tube is limited by a proximal abutment device and a distal abutment device, to a longitudinal movement between its first and second longitudinal positions. That provides that the two extreme positions are made clearly perceptible to the operator in a particularly simple and reliable fashion.
In this case, to form the proximal abutment device, a first abutment surface can be provided on the casing tube and a second abutment surface arranged in distal relationship therewith can be provided on the swab carrier or on the actuating grip. To form the distal abutment device, a third abutment surface is then also provided on the casing tube and provided on the swab carrier or on the actuating grip is a fourth abutment surface arranged in proximal relationship therewith. In that case, the second abutment surface, when the first longitudinal position of the swab carrier is reached, bears in a first contact region at least in part against the first abutment surface which is in proximal relationship therewith. In the opposite direction, the fourth abutment surface, when the second longitudinal position of the swab carrier is reached, bears in a second contact region at least in part against the third abutment surface which is in distal relationship therewith. The lines normal to the first and second abutment surfaces respectively extend over the first and second contact regions respectively in parallel relationship with the longitudinal direction. That configuration, by virtue of the orientation thereof, provides first and second abutment surfaces which can be produced in a simple fashion and which reliably limit the longitudinal movement of the swab carrier relative to the casing tube. In this case, the second and fourth abutment surfaces can be of any desired shape, whereby the production thereof can also be a very simple matter.
Preferably but not necessarily the first abutment surface is disposed in proximal relationship with the third abutment surface, as that then permits a particularly simple arrangement of the second and fourth abutment surfaces.
To provide the abutment devices, the arrangement may have a projection which extends radially with respect to the longitudinal axis and which is of a pin-like or nose-like configuration and which engages into a groove extending substantially in the longitudinal direction of the device. In that case the projection is provided at the inside periphery of the casing tube and the groove is then provided in the swab carrier. When the first longitudinal position of the swab carrier is reached the projection then bears against the distal end surface of the groove and when the second longitudinal position of the swab carrier is reached it bears against the proximal end surface of the groove.
Alternatively, the projection is provided at the outside periphery of the swab carrier and the groove extends on the inside of the casing tube. When the first longitudinal position of the swab carrier is reached the projection then bears against the proximal end surface of the groove and when the second longitudinal position of the swab carrier is reached it bears against the distal end surface of the groove.
Both variants are distinguished by being particularly simple to manufacture and by virtue of their operative principle which is reliable in operation because it is a simple mechanical principle.
Preferably, the casing tube and the swab carrier are adapted to be rotatable relative to each about the longitudinal axis, wherein the groove, for locking of the swab carrier in its first and/or second longitudinal position, is designed in the manner of a bayonet locking means at its proximal end and/or its distal end. That provides in a particularly desirable fashion for locking of the swab carrier relative to the casing tube, thereby ensuring simple and reliable handling of the device.
In other advantageous configurations of the device according to the invention the displacement device is designed in the manner of a screw drive which produces an advance movement in the longitudinal direction of the device, thereby affording a displacement mechanism which acts in a particularly simple and reliable fashion. Preferably in that case the casing tube and the swab carrier are adapted to be rotatable relative to each about the longitudinal axis. The displacement device includes a first screwthread which is arranged on the casing tube and which, for producing a longitudinal movement of the swab carrier relative to the casing tube, upon rotation of the actuating grip relative to the casing tube about the longitudinal axis, co-operates with a second screwthread provided on the swab carrier or on the actuating grip, and thus produces a longitudinal movement of the swab carrier relative to the casing tube.
This variant is distinguished by variability, which is particularly high together with ease of manufacture, in terms of the displacement parameters. Thus, it is readily possible to set the advance movement of the swab carrier relative to the casing tube, which is produced per revolution of the actuating grip, by a suitable choice of the screwthread pitch. In addition, multi-flight screwthreads can be provided to enhance the level of operating reliability.
There are a large number of different options in regard to the arrangement of the screwthreads. Thus, the first screwthread can be arranged in the form of a female screwthread on the casing tube while in that case, as will be readily appreciated, the second screwthread must be in the form of a male screwthread for example on the swab carrier. Preferably however the first screwthread is arranged at the outside periphery of the proximal end of the casing tube and the actuating grip is designed in the manner of a screw cap, in which case the swab carrier is passed through an orifice in coaxial relationship therewith at the distal end of the actuating grip and the second screwthread is arranged at the distal end of the actuating grip at the inside periphery of the orifice. That then affords a robust arrangement which is particularly simple to produce.
In particularly desirable variants of the invention, the pitch of the first and second screwthreads is so selected that the movement of the swab carrier from its first longitudinal position into its second one or vice-versa is implemented by substantially one revolution of the actuating grip relative to the casing tube. That affords a device which is particularly simple to handle and in which the advance movement of the swab carrier relative to the casing tube can be rapidly implemented by means of a single handling operation, with good and simple controllability. Preferably in that case the first screwthread and the second counterpart screwthread are of a multi-flight nature. That prevents jamming of the screw drive in a simple and thus inexpensive manner, this in turn ensuring noise-free operation of the device.
Preferably the casing tube and the swab carrier each comprise biocompatible plastic material and the coupling portion comprises biocompatible plastic material or biocompatible metal so that the risk of adversely affecting the examination results by damage to the smear or the transportation fluid by the material of the casing tube, swab carrier or coupling portion is minimized. In a further preferred feature the actuating grip is in the form of a plastic body produced by casting or injection blow molding. That permits particularly inexpensive manufacture of the actuating grip in a single working operation. That applies in particular also when the actuating grip is to be provided with a motion screwth read.
The swab preferably comprises calcium alginate or a cotton-aluminum mixture or is formed by a nylon brush as those materials ensure that it is particularly easy to take the smear and they do not involve any falsification, or they entail minimized falsification, of the examination results by virtue of an interaction with the smear or the transportation fluid.
It is also desirable if the outer actuating grip is xe2x80x9cnon-losablyxe2x80x9d latched on the inner grip element by virtue of an annular abutment surface being provided on the grip element which is connected to the sleeve, the annular abutment surface interacting with an annular abutment surface when the grip element comes free from the screwthread. That forms a blocking means to prevent the actuating grip from being pulled off the grip portion in the situation where the latter is completely unscrewed from the screwthread.
If the swab carrier is to be removed by means of a pair of tweezers, the tweezers can be packaged with the device, in which case a receiving means for the tweezers in the form of a clamping holder is preferably provided on the casing tube or on the grip portion.